FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (K220721)
Description
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 by Fresenius Medical Care Renal Therapies Group, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220721
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (K220721) cites 3 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2017 |
| K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND ... | Gambro Renal Products | 2005 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therap... | 2025 |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL ... | Fresenius Medical Care Renal Therap... | 2025 |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therap... | 2024 |
Trace the full predicate network for K220721
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.